What is FDA Form 483? These are the 3 types of FDA inspection reports you need to know!

You would never guess that during the FDA factory inspection process, there are 80% Taiwan cross-border sellers who step on the mine because they don't understand the FDA inspection report! Today I'm going to unveil the mystery of FDA inspection reports for cross-border e-commerce sellers: Form 483, EIR and Warning Letter, what are these three key documents?

What is FDA Form 483?

FDA Form 483, also known as the Field Observation Report, is a list of nonconformities found by an FDA inspector during an on-site inspection of a pharmaceutical company's quality system in accordance with cGMP regulations. It's like a "checklist of problems" that directly points out where your organization is not complying with U.S. standards!

Second, how serious are the FDA 483 deficiencies?

Attention! When an FDA inspector finds nonconformities and the factory is unable to complete the corrections within the extended period of time, these issues will be counted in the Form 483. The best part is that companies that receive a Form 483 have only 15 days to correct the problem! Failure to do so in such a short period of time may result in further action by the FDA:

1. Food companies may organize secondary factory inspections and may also charge by the hour.
2. For marketed products, the FDA will organize professional meetings to determine the corrective action or recall plan.
3. Even more frightening is that companies may be blacklisted and receive warning letters for failing to comply with GMP/cGMP requirements

What is a Factory Investigation Report (EIR)?

The EIR is the Establishment Investigation Report, which the inspecting official is required to produce in addition to the Form 483. This report is completed within 30 business days and is then inspected by the FDA Office of the Inspector General and ultimately identified as having one of the following three statuses:

1️⃣ NAI: No Action Indicated - No action required (no violations found during inspection)
2️⃣ VAI: Voluntary Action Indicated - Voluntary Action (found non-compliant items, but no official action required)
3️⃣ OAI: Official Action Indicated - Official Action Required (Further Regulatory Action Required if Breach Found)

How serious is a Warning Letter?

Warning letters are one of the most severe penalties imposed by the FDA! The FDA issues Warning Letters when an inspection reveals serious deficiencies and the response to the Form 483 is determined to be inadequate. Companies must respond within 15 business days with a detailed resolution. Most notably, the warning letter will be made public on the FDA's official website, which can have a huge impact on a brand's reputation!

For Taiwan-based cross-border e-commerce sellers who are preparing to enter the U.S. market, it's important to understand these FDA inspection reports. Want to get more information about FDA compliance and avoid stepping on the line?

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